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Point of Care Diagnostic Testing Sector Trends


Description: Point of care testing enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or even days for outside lab results to arrive. Point of care testing covers: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.

The purpose of this TriMark Publications report is to describe the sector trends within the point of care testing (POCT) diagnostic market. It examines those measurement devices and their reagents and supplies that are utilized in hospitals, clinics, commercial laboratories and research institutions to detect cells and proteins for the purpose of diagnosis and monitoring of disease. This study includes all of the generally-accepted clinical analytical activities that are currently in use today. Additionally, an analysis of business and technology trends and developing areas of point of care and HPV testing is provided, along with a review of the market for point of care testing equipment and supplies in the clinical and research market segments, using screening reagents and instruments for analysis of individual components in blood, serum or plasma. This report defines U.S. and global market dollar sales volume and analyzes factors that influence the size and growth of market segments.


Contents: 1. Overview
1.1 Statement of Report
1.2 Scope of This Report
1.3 Objectives
1.4 Methodology
1.5 Executive Summary

2. Overview of Point of Care Diagnostic Testing
2.1 Key Issues in the Point of Care Diagnostic Testing Sector
2.1.1 Current Market Trends and Drivers
2.1.2 Effectiveness of POCT
2.1.3 New Growth Areas for POCT
2.1.4 Advantages of POCT in a Clinical Setting
2.1.5 Pricing and Reimbursement Issues
2.1.6 Key Customer Segments
2.2 Global Point of Care Marketplace
2.3 Shifts from Central Lab Testing to POCT
2.4 Geographical Distribution
2.5 Emerging New Technologies
2.6 Challenges of POCT
2.7 Key Issues for POCT
2.7.1 Locations of POCT
2.7.2 Milestones in Technology Development
2.7.3 Drive for Decentralization from Lab to Patient
2.7.4 Expanded Reimbursement
2.7.5 Competitive Landscape for POCT
2.8 The Future of POCT

3. POC and Rapid Testing Market: Summary of Market Analysis: Size, Background, Growth, Share and Competitors
3.1 Global POCT Market

4. U.S. POCT Market

5. European POCT Market

6. Japanese POCT Market Sector Trends

7. Chinese POCT Market Sector Trends

8. Indian POCT Market Sector Trends

9. The Rest of the World (ROW) POCT Market

10. The Role of POCT in Critical Care
10.1 Technological Diversity in POCT
10.1.1 The Wide Range of Point of Care Assays
10.1.2 Challenge of Testing on a Single Platform
10.1.3 Connectivity with Testing Platforms
10.1.4 Improvement in Clinical Outcomes with Use of POCT
10.1.5 Future Developments
10.2 Point of Care Addresses Critical Requirements
10.2.1 Needs in Critical Care Testing
10.2.2 Point of Care Instrument Key Elements
10.2.3 Key Advancements--Menu, Quality Assurance (QA), Connectivity, Internet Access
10.2.4 Standardized System for All Testing Locations
10.3 POCT versus Central Laboratory Testing
10.3.1 The Financial Advantages of POCT
10.3.2 Is the Shift Towards Point of Care Justified?
10.3.3 Overall Cost Benefit
10.3.4 More Available Time for Clinical Practitioners
10.3.5 Future Policies

11. POCT Sector Trends and Market Predictions

12. Business Trends in the Point of Care Sector
12.1 Sector Consolidation
12.2 Acquisition, License Agreements, Internal Development and Partnerships
12.3 The Ideal Acquisition Profile
12.3.1 Markets of Interest for Acquisition of POCT
12.3.2 Key M&A Steps
12.4 Product Breadth in POCT
12.5 Companies Exiting From POCT
12.6 Increased Market Penetration
12.7 Costs of Doing Business in Europe
12.8 Drivers of European Diagnostics Testing
12.9 European Reimbursement Practices
12.10 Cost Containment in Europe
12.11 Significant Factors that Provide Competitive Advantage
12.12 Sales and Marketing Strategies for POCT
12.12.1 North American Market
12.12.2 International Markets
12.12.2.1 Europe
12.12.2.2 Central and South America
12.12.2.3 Asia-Pacific

13. Biotechnology Industry Trends
13.1 Pharmaceutical Industry Trends

14. Government Regulation
14.1 Government Regulation
14.1.1 U.S. Regulation
14.1.1.1 Importing Medical Devices into the U.S.
14.1.1.2 Exporting Medical Devices from the U.S.
14.1.2 E.U. Regulations
14.1.3 Japanese Regulations
14.1.4 Korean Regulations
14.2 Post Filing Regulations for Point of Care Devices
14.3 Exporting Unapproved POCTs
14.4 Analyte Specific Reagents (Home Brew Tests)
14.5 Medical Device Registration
14.6 Product Labeling
14.7 Punitive FDA Actions
14.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws
14.9 Impact of Regulations on the Industry
14.10 Minimizing Regulatory Barriers
14.11 Waived Testing

15. Limited Reimbursements by Third-Party Payers Obstruct Sales
15.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales
15.2 Reimbursement Codes Classification
15.3 Point of Care Product Line Reimbursement Picture

16. Barriers to Business
16.1 Concentration of Customers
16.2 Intense Competition from Other Companies
16.3 Protection of Intellectual Property Rights
16.4 Physician Acceptance
16.5 Current Levels of Market Growth for POCT Procedures May Not be Indicative of Future Growth
16.6 Additional Applications of Technology Platform
16.7 Management of Growth
16.8 Difficulty of Establishing a Marketing Infrastructure

17. Company Profiles
17.1 Abaxis, Inc.
17.2 Abbott Diagnostics
17.3 Accumetrics, Inc.
17.4 Accurex Biomedical Pvt. Ltd.
17.5 AgaMatrix
17.6 Akers Bioscience, Inc. (ABI)
17.7 Alfa Scientific Design, Inc.
17.8 Alere Health, LLC
17.9 Ambri Ltd.
17.10 American Bio Medica Corporation
17.11 Ani Biotech
17.12 Apogent Technologies
17.13 Ark Therapeutics
17.14 ARKRAY, Inc.
17.15 Atlas Genetics
17.16 Atonomics A/S
17.17 Avox Systems
17.18 Axis-Shield
17.19 Bayer Corp.
17.20 Beacon Diagnostics, Inc.
17.21 Beckman Coulter
17.22 Binax Corporation
17.23 Biomerica, Inc.
17.24 bioMerieux
17.25 BioScan Screening Systems, Inc.
17.26 Biosite Diagnostics
17.27 British Biocell Holdings
17.28 Caliper Life Sciences
17.29 Calypte Biomedical Corporation
17.30 Chembio Diagnostics, Inc.
17.31 Cholestech
17.32 CompuCyte Corporation
17.33 Cozart Bioscience
17.34 Cygnus Therapeutic Systems
17.35 Cytogen Corporation
17.36 Dade Behring
17.37 Daiichi Sankyo Group
17.38 Denka Seiken Co., Ltd.
17.39 Diagnostic Chemicals Ltd.
17.40 EY Laboratories, Inc.
17.41 Enterix, Inc.
17.42 Focus Diagnostic, Inc.
17.43 GDS Technology
17.44 GenBio
17.45 Genzyme Diagnostics
17.46 Grant Life Sciences, Inc.
17.47 Gryphus Diagnostics, LLC
17.48 Guided Therapeutics, Inc.
17.49 Harring Group Ltd. (HGR)
17.50 Helena Laboratories
17.51 Hema Diagnostic Systems, LLC
17.52 HemoCue, Inc.
17.53 Home Access Health Corp.
17.54 i-STAT Corporation
17.55 ImmunoScience, Inc.
17.56 Instrumentation Laboratory
17.57 International Medical Innovations
17.58 Johnson & Johnson
17.59 LifeAssays AB
17.60 MediSense
17.61 Medisys
17.62 Medix Biochemica
17.63 MedMira Laboratories
17.64 Medtronic
17.65 A Menarini Diagnostics
17.66 Meretek Diagnostics Group
17.67 Meridian Bioscience
17.68 MiniMed
17.69 Mitsubishi Chemical USA, Inc.
17.70 Mitsubishi Kagaku Iatron
17.71 Nanogen (ELITech Group)
17.72 New Horizons Diagnostics
17.73 Nova Biomedical
17.74 OraSure Technologies, Inc.
17.75 Orgenics
17.76 Orion Diagnostica
17.77 PanBio Ltd.
17.78 Phamatech, Inc.
17.79 PharmaNetics, Inc.
17.80 Polymedco, Inc.
17.81 Polymer Technology Systems, Inc.
17.82 Princeton BioMeditech Corporation
17.83 Quest Diagnostics, Inc.
17.84 Quidel Corporation
17.85 Radiometer
17.86 Response Biomedical Corp.
17.87 Roche Diagnostics
17.88 Savyon Diagnostics
17.89 Selfcare, Inc.
17.90 Shionogi & Co., Ltd.
17.91 Siemens Corporation
17.92 Guided Therapeutics (SpectRx, Inc.)
17.93 Spectral Diagnostics
17.94 StatSure Diagnostic Systems, Inc.
17.95 Strategic Diagnostics
17.96 Trinity Biotech, Plc
17.97 Vasamed, Inc.

18. FDA Currently Waived Tests

INDEX OF FIGURES

Figure 14.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device
Category 108


INDEX OF TABLES

Table 2.1: POCT Frequency in Hospitals 18
Table 2.2: Worldwide Distribution of IVD Testing, 2010 19
Table 2.3: Top Thirteen Country IVD Testing Markets, 2010 20
Table 2.4: Common Genotype Techniques 22
Table 2.5: Competitive Landscape for Point of Care Diagnostic Testing 33
Table 3.1: Total Global POCT Market, 2007-2017 36
Table 3.2: Global Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 37
Table 3.3: Global Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017 37
Table 3.4: Global Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 38
Table 3.5: Global Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017 38
Table 3.6: Global Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market, 2007-2017 39
Table 3.7: Global Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 39
Table 3.8: Global Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 40
Table 3.9: Global Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 40
Table 3.10: Global Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 41
Table 3.11: Global Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 41
Table 3.12: Global Market Share Analysis, 2010 42
Table 4.1: Total U.S. POCT Market for Blood Glucose Monitoring Systems, 2007-2017 43
Table 4.2: U.S Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 43
Table 4.3: U.S Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017 44
Table 4.4: U.S. Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 44
Table 4.5: U.S. Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017 45
Table 4.6: U.S. Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market, 2007-2017 45
Table 4.7: U.S. Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 46
Table 4.8: U.S. Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 46
Table 4.9: U.S. Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 47
Table 4.10: U.S. Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 47
Table 4.11: U.S. Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 48
Table 4.12: U.S. Market Share Analysis, 2010 48
Table 5.1: Models of Public-Private Partnership in Hospital Provision 50
Table 5.2: European Revenue Forecasts for POCT Market, 2007-2017 53
Table 5.3: European Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 54
Table 5.4: European Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017 54
Table 5.5: European Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 55
Table 5.6: European Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017 56
Table 5.7: European Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market,
2007-2017 57
Table 5.8: European Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 58
Table 5.9: European Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 58
Table 5.10: European Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 59
Table 5.11: European Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 60
Table 5.12: European Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 60
Table 5.13: European Market Share Analysis, 2010 61
Table 6.1: Total Japanese POCT Market, 2007-2017 62
Table 6.2: Japanese Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 63
Table 6.3: Japanese Revenue Forecasts for POC Blood Gas and Electrolytes Systems Analysis, 2007-2017 63
Table 6.4: Japanese Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 64
Table 6.5: Japanese Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017 64
Table 6.6: Japanese Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market,
2007-2017 65
Table 6.7: Japanese Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 65
Table 6.8: Japanese Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 66
Table 6.9: Japanese Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 66
Table 6.10: Japanese Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 67
Table 6.11: Japanese Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 67
Table 6.12: Japanese Market Share Analysis, 2010 68
Table 9.1: ROW Revenue Forecasts for POC Market, 2007-2017 71
Table 9.2: ROW Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 71
Table 9.3: ROW Revenue Forecasts for POC Blood Gas and Electrolytes Systems Analysis, 2007-2017 72
Table 9.4: ROW Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 72
Table 9.5: ROW Revenue Forecasts for POC Cardiac Marker Devices Market, 2007-2017 73
Table 9.6: ROW Revenue Forecasts for POC Substance/Drug Abuse Testing Devices Market, 2007-2017 73
Table 9.7: ROW Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 74
Table 9.8: ROW Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 74
Table 9.9: ROW Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 75
Table 9.10: ROW Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 75
Table 9.11: ROW Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 76
Table 9.12: ROW Market Share Analysis, 2010 76
Table 10.1: Customized Reports Must Support CAP and JCAHO Requirements 82
Table 17.1: Abaxis, Inc. Financial Figures--Net Sales by Business Sector, 2008-2010 126
Table 17.2: Abaxis, Inc. Financial Figures--Net Sales by Geographic Region, 2008-2010 127
Table 17.3: Abbott Laboratories Financial Figures--Net Sales by Business Sector, 2008-2010 128
Table 17.4: Abbott Laboratories Financial Figures--Net Sales by Geographic Region, 2008-2010 128
Table 17.5: Bayer AG Financial Figures--Net Sales by Business Sector, 2008-2010 137
Table 17.6: Bayer AG Financial Figures--Net Sales by Geographic Region, 2008-2010 138
Table 17.7: Johnson & Johnson Financial Figures--Net Sales by Major Medical and Diagnostics Businesses,
2008-2010 154
Table 17.8: Medtronic Financial Figures--Net Sales by Segment, 2008-2010 158
Table 17.9: Quidel Product Sales Distribution and Sales, 2009 and 2010 171
Table 17.10: Danaher Corporation Financial Figures--Net Sales by Business Sector, 2008-2010 175
Table 17.11: Danaher Corporation Financial Figures--Net Sales by Geographic Region, 2008-2010 175
Table 17.12: Roche Group Financial Figures--Net Sales by Business Sector, 2008-2010 179
Table 17.13: Roche Group Financial Figures--Net Sales by Geographic Region, 2009 and 2010 179
Table 17.14: Roche Group Financial Figures--Net Sales by Sub-Division, 2008-2010 179

Table 2.1: POCT Frequency in Hospitals 14
Table 2.2: Worldwide Distribution of IVD Testing in 2008 16
Table 2.3: Top Twelve Country IVD Testing Markets, 2007 16
Table 2.4: Competitive Landscape for Point of Care Diagnostic Testing 23
Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2008 24
Table 3.2: Number of POCTs in U.S., 2004-2012 25
Table 3.3: Overall In Vitro Diagnostic Testing Market Worldwide, 2007 26
Table 3.4: Largest Diagnostic Companies Worldwide, 2007 26
Table 3.5: Global Point of Care Revenues, 2005-2012 27
Table 3.6: Worldwide Distribution of POCT, 2008 27
Table 3.7: Professional Glucose Testing Market for POCT Worldwide, 2001-2012 28
Table 3.8: U.S. POCT Market, 2000-2012 28
Table 3.9: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2008 29
Table 3.10: U.S. POCT by Performance Location, 2008 29
Table 3.11: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 30
Table 3.12: U.S. POCT Glucose Testing Market, 2003-2012 30
Table 3.13: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-2012 30
Table 3.14: U.S. POCT Coagulation Market Size, 2003-2012 31
Table 3.15: U.S. POCT Cardiac Markers Market Size, 2003-2012 31
Table 3.16: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-2012 31
Table 3.17: U.S. POCT Urinalysis Market Size, 2003-2012 32
Table 3.18: Manufacturer Market Share U.S. POCT Market, 2008 32
Table 3.19: Manufacturer Market Share U.S. POCT Market Glucose Testing, 2008 32
Table 3.20: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2008 33
Table 3.21: Manufacturer Market Share U.S. POCT Coagulation Market, 2008 33
Table 3.22: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2008 33
Table 3.23: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 34
Table 3.24: European POCT Market, 2005-2012 35
Table 3.25: European POCT Diagnostics Market, 2007 35
Table 3.26: Top Twelve Country IVD and POC Testing Markets, 2007 36
Table 3.27: Japan POCT Market, 2005-2012 36
Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements 42
Table 12.1: Products Marketed by Abbott in the Diagnostic Market 86
Table 12.2: Quidel Product Sales Distribution and Sales, 2006-2008 139
Table 12.3: Key Products 146


Companies Mentioned - Abaxis, Inc. - Abbott Diagnostics - Accumetrics, Inc. - Accurex Biomedical Pvt. Ltd. - AgaMatrix - Akers Bioscience, Inc. (ABI) - Alfa Scientific Design, Inc. - Alere Health, LLC - Ambri Ltd. - American Bio Medica Corporation - Ani Biotech - Apogent Technologies - Ark Therapeutics - ARKRAY, Inc. - Atlas Genetics - Atonomics A/S - Avox Systems - Axis-Shield - Bayer Corp. - Beacon Diagnostics, Inc. - Beckman Coulter - Binax Corporation - Biomerica, Inc. - bioMerieux - BioScan Screening Systems, Inc. - Biosite Diagnostics - British Biocell Holdings - Caliper Life Sciences - Calypte Biomedical Corporation - Chembio Diagnostics, Inc. - Cholestech - CompuCyte Corporation - Cozart Bioscience - Cygnus Therapeutic Systems - Cytogen Corporation - Dade Behring - Daiichi Sankyo Group - Denka Seiken Co., Ltd. - Diagnostic Chemicals Ltd. - EY Laboratories, Inc. - Enterix, Inc. - Focus Diagnostic, Inc. - GDS Technology - GenBio - Genzyme Diagnostics - Grant Life Sciences, Inc. - Gryphus Diagnostics, LLC - Guided Therapeutics, Inc. - Harring Group Ltd. (HGR) - Helena Laboratories - Hema Diagnostic Systems, LLC - HemoCue, Inc. - Home Access Health Corp. - i-STAT Corporation - ImmunoScience, Inc. - Instrumentation Laboratory - International Medical Innovations - Johnson & Johnson - LifeAssays AB - MediSense - Medisys - Medix Biochemica - MedMira Laboratories - Medtronic - A Menarini Diagnostics - Meretek Diagnostics Group - Meridian Bioscience - MiniMed - Mitsubishi Chemical USA, Inc. - Mitsubishi Kagaku Iatron - Nanogen (ELITech Group) - New Horizons Diagnostics - Nova Biomedical - OraSure Technologies, Inc. - Orgenics - Orion Diagnostica - PanBio Ltd. - Phamatech, Inc. - PharmaNetics, Inc. - Polymedco, Inc. - Polymer Technology Systems, Inc. - Princeton BioMeditech Corporation - Quest Diagnostics, Inc. - Quidel Corporation - Radiometer - Response Biomedical Corp. - Roche Diagnostics - Savyon Diagnostics - Selfcare, Inc. - Shionogi & Co., Ltd. - Siemens Corporation - Guided Therapeutics (SpectRx, Inc.) - Spectral Diagnostics - StatSure Diagnostic Systems, Inc. - Strategic Diagnostics - Trinity Biotech, Plc - Vasamed, Inc.


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